Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

safety, efficacy and acceptability of Flavocoxid

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

NCT00928837

Osteoarthritis

COMPLETED NA

Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

NCT00435292

Osteoarthritis

COMPLETED NA

Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee

NCT00790985

Osteoarthritis of Knee

COMPLETED NA

Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

NCT00638807

Osteoarthritis, Knee

COMPLETED PHASE4

Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen

NCT00640627

Osteoarthritis, Knee

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

flavocoxid

medical food

Group Type EXPERIMENTAL

flavocoxid

Intervention Type DIETARY_SUPPLEMENT

flavonoid mixture

naproxen

NSAID

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

non-steroidal anti-inflammatory drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flavocoxid

flavonoid mixture

Intervention Type DIETARY_SUPPLEMENT

Naproxen

non-steroidal anti-inflammatory drug

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Limbrel naprosyn

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -

Exclusion Criteria

pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids

\-

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No